NCT03373331

Brief Summary

The current project will examine the impact of an emotional processing intervention on emotional processing abilities in a sample of 50 persons with moderate to severe TBI. Outcome will be assessed across 3 domains. We will document changes resulting from treatment: (1) in emotional processing tasks (2) in other areas of function including QOL, social functioning, mood and cognition that are also likely to be impacted (3) in brain structure and function. The examination of efficacy in the above three areas will further our knowledge of emotional processing deficits in TBI and more importantly, identify an effective means of treating such deficits.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

December 8, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 14, 2017

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

February 25, 2021

Status Verified

February 1, 2021

Enrollment Period

5.7 years

First QC Date

December 8, 2017

Last Update Submit

February 23, 2021

Conditions

Traumatic Brain Injury

Keywords

Emotional ProcessingCognitionTraumatic Brain InjuryIntervention

Outcome Measures

Primary Outcomes (1)

  • Facial Expression Identification Task (FEIT)

    The FEIT assesses one's ability to correctly identify and discriminate emotions from faces.

    Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)

Secondary Outcomes (2)

  • Emotion Regulation Questionnaire (ERQ)

    Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)

  • Satisfaction with Life Scale (SWLS)

    Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)

Study Arms (2)

Experimental Group

EXPERIMENTAL

Participants in the experimental group will receive emotional processing training exercises administered on a laptop computer. They will undergo 12 sessions of 45-60 minutes each (twice a week for 6 weeks).

Behavioral: Emotional Processing Training

Control Group

PLACEBO COMPARATOR

Participants in the control group will meet with the examiner the same frequency and for the same duration as those in the experimental group. They will receive placebo control exercises administered on a laptop computer. .

Behavioral: Placebo Control Exercises

Interventions

Emotional Processing TrainingBEHAVIORAL

Participants in the experimental group will receive computerized exercises administered on a laptop computer. They will undergo 12 sessions of 45-60 minutes each (twice a week for 6 weeks).

Experimental Group
Placebo Control ExercisesBEHAVIORAL

Participants in the control group will receive computerized control exercises administered on a laptop computer. They will undergo 12 sessions of 45-60 minutes each (twice a week for 6 weeks).

Control Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of Traumatic Brain Injury (TBI)
  • can read and speak English fluently

You may not qualify if:

  • prior stroke or neurological disease.
  • history of significant psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis) or a current diagnosis of Major Depressive Disorder, Schizophrenia, Epilepsy, Bipolar Disorder
  • significant alcohol or drug abuse history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kessler Foundation

East Hanover, New Jersey, 07936, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Helen Genova, PhD

    Kessler Foundation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Angela Smiith, MA

CONTACT

973-324-8448asmith@kesslerfoundation.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist

Study Record Dates

First Submitted

December 8, 2017

First Posted

December 14, 2017

Study Start

September 1, 2015

Primary Completion

May 1, 2021

Study Completion

May 1, 2021

Last Updated

February 25, 2021

Record last verified: 2021-02

Locations

US(1)